MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 5530030

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis : visual and microscopic examination of the returned set screw identified the upper flanks of the set screw surface is skived, starting at the start of the thread, with a thin portion of the upper flank removed.This damage is consistent with overloading the set screw thread due to incomplete seating of the rod in the mas saddle.

Event Description

It was reported that patient underwent thoracic, lumbar and sacral spine posterior correction fusion surgery at th10-s2ai due to kyphosis scoliosis.Intra-op, burr occurred during insertion of a set screws.It was changed with new one to continue the surgery.Fragments of the implant remaining in the patient were unknown.No patient complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5836133
• MDR Text Key: 50815430
• Report Number: 1030489-2016-02236
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• Device Catalogue Number: 5530030
• Device Lot Number: H5243860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: 07/04/2016
• Supplement Dates FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1